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Archives of Physical Medicine and Rehabilitation

journal homepage: www.archives-pmr.org


Archives of Physical Medicine and Rehabilitation 2019;-:-------

REVIEW ARTICLE

Abstracts of Low Back Pain Trials Are Poorly Reported,


Contain Spin of Information, and Are Inconsistent
With the Full Text: An Overview Study
Dafne P. Nascimento, PhD,a Leonardo O.P. Costa, PhD,a Gabrielle Z. Gonzalez, PhD,a
Christopher G. Maher, PhD,b Anne M. Moseley, PhDb
From the aMasters and Doctoral Programs in Physical Therapy, Universidade Cidade de Sao Paulo, Sao Paulo, Brazil; and bMusculoskeletal
Health Sydney, School of Public Health, The University of Sydney, Sydney, Australia.

Abstract
Objective: To investigate trials abstracts evaluating treatments for low back pain with regard to completeness of reporting, spin (ie, interpretation
of study results that overemphasizes the beneficial effects of the intervention), and inconsistencies in the data with the full text.
Data Sources: The search was performed on the Physiotherapy Evidence Database (PEDro) in February 2016.
Study Selection: This is an overview study of a random sample of 200 low back pain trials published between 2010 and 2015. The languages of
publication were restricted to English, Spanish, and Portuguese.
Data Extraction: Completeness of reporting was assessed using the Consolidated Standards of Reporting Trials (CONSORT) for abstracts
checklist (CONSORT-A). Spin was assessed using a spin checklist. Consistency between abstract and full text was assessed by applying the
assessment tools to both the abstract and full text of each trial and calculating inconsistencies in the summary score (paired t test) and agreement
in the classification of each item (kappa statistics). Methodologic quality was analyzed using the total PEDro score.
Data Synthesis: The mean number of fully reported items  SD for abstracts using the CONSORT-A was 5.12.4 out of 15 points. The mean
number of items  SD with spin was 4.92.6 out of 7 points. Abstract and full text scores were statistically inconsistent (PZ.01). There was
slight to moderate agreement between items of the CONSORT-A in the abstracts and full text (mean kappa  SD, 0.200.13) and fair to moderate
agreement for items of the spin checklist (mean kappa  SD, 0.470.09).
Conclusions: The abstracts were incomplete, with evidence of spin and inconsistent with the full text. We advise health care professionals to
avoid making clinical decisions based solely upon abstracts. Journal editors, reviewers, and authors are jointly responsible for improving abstracts,
which could be guided by amended editorial policies.
Archives of Physical Medicine and Rehabilitation 2019;-:-------
ª 2019 by the American Congress of Rehabilitation Medicine

Health care professionals use the results of randomized effects.2 These exaggerated effects can be generated either due to
controlled trials to assist their clinical decision making.1 How- bias in the conduct of the trials or bias in the reporting of
ever, they should be mindful that trials that are not adequately the trials.3,4
conducted and reported may tend to overestimate treatment Reading the full report of trial results is necessary to critically
appraise evidence.5,6 However, many health care professionals
decide to read the full text of an article only after reading the
abstract and some may only have easy access to the abstract.6,7
Presented to the World Confederation for Physical Therapy, July 2e4, 2017, Cape Town,
South Africa; and to the International Back and Neck Pain Research Forum, September 12e15,
Therefore, the completeness of abstracts and consistency with
2017, Oslo, Norway. full text are important, also because trial abstracts are also widely
Supported by the Sao Paulo Research Foundation (grant no. 2015/16953-2), which was con- used in the screening process of systematic reviews.8 Common
ducted as part of a PhD undertaken by D.P.N.
Disclosures: The authors declare that, even though 7 out of the 200 articles analyzed involved
problems with abstracts include incomplete and inadequate
authors from our research groups, all articles were evaluated with the same criteria and rigor. reporting9,10 and inconsistencies between abstract and the full

0003-9993/19/$36 - see front matter ª 2019 by the American Congress of Rehabilitation Medicine
https://doi.org/10.1016/j.apmr.2019.03.024
2 D.P. Nascimento et al

text.11 Studies that have examined completeness of trial ab- Methods


stracts12-17 using the Consolidated Standards of Reporting Trials
(CONSORT) for abstracts (CONSORT-A) checklist7 concluded
that completeness of reporting of abstracts was poor. There ap- Eligibility criteria
pears to be an association between completeness of reporting and This is an overview study of 200 trials reporting the results of
the number of centers,14 continent where the trial was conduct- randomized controlled trials, both abstracts and full text. First, we
ed,18,19 abstract format,14 and year of publication of a trial.18,19 searched for all randomized controlled trials coded as low back
Shiwa et at20 concluded that English trials were more likely to pain, and published between 2010 and 2015, that were indexed on
have better methodologic quality than trials written in other lan- the Physiotherapy Evidence Database (PEDro). We then selected a
guages, therefore, completeness of reporting of abstracts might random sample of 40% from all potentially eligible trials for the
also be related to the language. Studies have also found associa- study. The selection was performed using the random number
tions between better reporting quality and higher impact factor function in Excel.a PEDro was used because it is one of the most
journals,12,14,18,19 journals endorsement of the CONSORT rec- complete indices of published reports of the results of randomized
ommendations,12,21 and abstracts with higher word counts.16 controlled trials evaluating physiotherapy interventions, with no
Studies that have compared abstracts and full texts in sports restrictions on language or journal of publication.38 In addition, all
injury prevention,17 general medicine,22 pharmacy,23 and psy- trial reports indexed on PEDro are rated for methodologic quality
chology24 found inconsistencies in 13% to 80% of articles. using the PEDro scale,39 which enabled us to include methodo-
Spin of information25-27 is another factor that can influence the logic quality as an independent variable in the analyses of trial
interpretation of abstracts. In research, spin is defined as “a characteristics associated with abstract completeness. The eligi-
misrepresentation of study results, regardless of motive (inten- bility criteria were a full-published trial reporting the results of a
tionally or unintentionally) that overemphasizes the beneficial randomized controlled trial evaluating at least 1 physiotherapy
effects of the intervention and overstates safety compared with intervention for low back pain; published in 2010 to 2015; in-
that shown by the results.”28(p2) Spin may occur in a journal clusive; and written in English, Spanish, or Portuguese. The search
publication, academic press releases, or media coverage of strategy performed on PEDro was “clinical trial” for method;
research.27,29-32 A study conducted in the oncology field33 eval- “lumbar spine, sacroiliac joint, or pelvis” for body part; “pain” for
uated the impact of spin of results in trials abstracts using a 7-item problem; 2010 to 2015 for year of publication; and English,
spin checklist and showed inconsistencies with the full text, such Spanish, or Portuguese for language. This time period was
as selective reporting and overstated treatment effects. To the best selected as it was after the release of the CONSORT-A in 20087;
of our knowledge, there is no study investigating the association therefore, we believe that authors would be prone to use these
between abstract completeness of reporting and spin of informa- recommendations. The language of publication was restricted to
tion, or even associating spin in abstracts with journal and trial English, Spanish, and Portuguese, as these were the languages
characteristics. spoken by the authorship team of this study and are among the
The issues of abstracts completeness, spin, and inconsistencies most common languages of publication on PEDro.40
with the full text have not been investigated in the low back pain
field. This is an important gap to address, as low back pain is
ranked the highest of all diseases for years lived with disability Data collection
and involves high costs worldwide.34,35 A recent publication in
one of the world’s leading general medical journals stated that Data extraction was divided into 5, to answer our research ques-
nonpharmacologic interventions, such as physiotherapy (including tions: (1) completeness of reporting of abstracts; (2) spin of in-
exercise, education, graded activity, manual therapy), is the formation in abstracts; (3) abstract inconsistencies with the full
preferred first-line treatment option for low back pain36 and is text; (4) association of abstract completeness and abstract spin
congruent with guideline recommendations.37 Our primary ques- with trial and journal characteristics; and (5) association of ab-
tions were (1) are abstracts of low back pain randomized stract spin with negative results. These sections are described in
controlled trials incomplete as assessed with the CONSORT-A? detail below. Two independent authors extracted data. Disagree-
(2) do these abstracts contain spin as assessed with the spin ments were resolved by discussion or arbitration by a third author.
checklist? and (3) are these abstracts inconsistent with the full text Agreement of data extraction between raters before consensus was
in completeness and spin? Our secondary questions were (4) is calculated using kappa statistics.41 The agreement was calculated
these abstracts’ completeness associated with certain trial or for each item of the CONSORT-A and the spin checklist for both
journal characteristics? and (5) is abstracts’ spin associated with abstract and full text.
“negative results” (ie, lack of statistical difference for primary
outcomes reported, or no difference for primary outcomes re- Completeness of reporting of abstracts
ported at all)?
The 17-item CONSORT-A7 was used to evaluate completeness of
reporting of the abstracts of the included trials. However, we
omitted 2 items in our data analyses because they were not rele-
vant to published articles of completed trials: “authors” (ie, related
to reporting of the contact details for the corresponding author in
List of abbreviations: conference proceedings) and “recruitment” (ie, indicates phase of
CONSORT Consolidated Standards of Reporting Trials recruitment or ongoing). We then modified the CONSORT-A to 15
CONSORT-A Consolidated Standards of Reporting Trials items. Each item was classified as “fully reported” (if reported all
for abstracts information specified in the item) and “not reported” (if partially
PEDro Physiotherapy Evidence Database
reported the information specified in the item, if no information

www.archives-pmr.org
Abstracts of low back pain trials 3

specified in the item was reported, or when primary outcomes the CONSORT-A: if we had classified the results for a primary
were not specified) for each trial. We also generated a summary outcome as “fully reported” in the abstract and in the full text we
score (CONSORT-A score) for each trial by counting the number found out there were 2 primary outcomes which were also “fully
of items that were “fully reported.” The summary score could reported,” we would downgrade the item in the abstract to
range from 0 (low level of completeness of reporting) to 15 “not reported”).
(high level of completeness of reporting).
We considered primary outcomes to be those identified as Description of trial and journal characteristics
“primary outcome” or “main outcome,” or any synonyms of the
word “outcome” (eg, endpoint). For trials that presented 1 or 2 To investigate if trial and journal characteristics were associated
outcomes only, we considered them as primary. with abstract completeness and with abstract spin, we defined 2
dependent variables and 10 independent variables. The dependent
Spin of information in abstracts variables were the CONSORT-A score and the spin-abstract score.
The independent variables were: trial conducted in more than 1
We used a 7-item spin checklist33 to evaluate spin of information center; continent where trial was conducted; language of publi-
in an abstract by comparing the abstract conclusion to the abstract cation; 2015 journal impact factor; if journal endorses the CON-
results. The list has been previously used to measure spin in SORT recommendations; number of words in abstract; structured
abstracts of randomized controlled trials in the field of oncology.33 abstract; total PEDro score; spin-abstract score; and number of
Each item (items are listed in the results section) was classified as years since trial publication. For the independent variables, we
“yes” (ie, the spin was clearly present, the primary outcome classified each trial as unicenter or multicenter (ie, if the study had
results were not reported, or the primary outcome results were been conducted in 1 or more centers). The country where the study
omitted, all of which represented that the spin was also present) or was conducted was extracted and categorized into continents
“no” (ie, the spin was not present). For example, if the authors of (using dummy variables for “Asia,” “Africa,” “Europe,” “North
the abstract gave a positive interpretation for a nonsignificant America,” “Oceania,” and “South America”). The language was
result, we would classify item 6 (overenthusiastic interpretation of classified as English or non-English. The journal impact factors
outcomes) as “yes.” A summary score (spin-abstract score) was from 2015 were downloaded from the aggregated journal citations
calculated by counting the items classified as “yes” (items clas- list, Journal Citation Reports.b Journal endorsement of the CON-
sified as “no” were considered free of spin of information). The SORT recommendations44 was extracted from the “Instructions to
summary score could range from 0 (low levels of spin) to 7 Authors” section for each of the journals or from the CONSORT
(high levels of spin). At this point, the abstract was assessed in recommendations’ website.45 The number of words in the abstract
isolation (not compared to the full text). We did this because was counted using the Microsoft Worda “word count” function.
readers should be able to interpret the trial based on the results The abstracts were classified as structured or not structured.46 The
section of the abstract. total PEDro score (0-10 points, higher values indicate better
The criterion for clinically important effects proposed by methodologic quality) was downloaded from PEDro. The number
Ostelo et al42 was used when scoring item 7 of the spin checklist. of years since trial publication was calculated by subtracting the
These is a: 15-point difference for the visual analog scale year of publication from 2015.
(0-100 points), 2-point difference for the numeric rating scale
(0-10 points), 5-point difference for the Roland Morris Description of negative results
Disability Questionnaire (0-24 points), 10-point difference for
the Oswestry Disability Index (0-100 points), and 20-point dif- To investigate if trial negative results (ie, statistically nonsignifi-
ference for the Quebec Back Pain Disability Scale (0-100 points). cant or not reported between-group differences for the primary
outcomes) were associated with spin we defined 7 independent
Abstracts inconsistencies with the full text variables (the individual items of the spin checklist) and 1
dependent variable (presence of statistically significant between-
Abstracts should reflect exactly what the full texts reported. Ab- group differences). The presence of statistical between-group
stracts have been compared to their corresponding full texts in differences was determined for primary outcomes (2 at most and
terms of completeness of reporting of all sections of a study and preferably pain and disability) and considering up to 4 interven-
spin of information in the results and conclusion sections.11,43 tion groups (the maximum number of groups from the included
We used the CONSORT-A and the spin checklist to evaluate trials), through confidence intervals (CIs) or P values. If the sta-
inconsistencies in completeness of reporting and presence of spin tistical between-group difference was in the opposite direction of
between the abstract and the corresponding full text, and the the hypothesis for at least 1 primary outcome, the trial was clas-
reason why we also applied the CONSORT-A and the spin sified as “no” (or no statistical between-group difference). If the
checklist in the full texts. Summary scores were calculated for the between-group difference was not reported for at least 1 primary
full text (CONSORTefull text score and spinefull text score) in outcome, the trial was classified as “not reported.” If all primary
order to be comparable to the abstract (CONSORT-A score and outcomes had statistical between-group differences (in the direc-
spin-abstract score). It was not our intention to analyze tion of the hypothesis), the trial was classified as “yes.” The trials
completeness of reporting of full texts themselves. In addition to classified as “no” and “not reported” were considered to have
that, for each individual item from the CONSORT-A and the spin negative results.
checklist, we calculated the agreement of how the item was For descriptive analysis we also collected the maximum
classified in the abstract with how it was classified in the full text. number of words allowed in the abstract by the publishing journal.
Each full text was evaluated immediately after its abstract. If an This was extracted from the “Instructions to Authors” section.
item of the full text was inconsistent with information reported in Trial abstracts were classified into 4 categories: those that adhered
the abstract, we would rescore such item in the abstract (eg, using to word limit (ie, word count within 10 words of the word limit);

www.archives-pmr.org
4 D.P. Nascimento et al

Identification
Records identified through database
searching
(n = 25.959)

Screening

Records screened
(n = 537)

Records excluded, with reasons (n = 67)

Ongoing study (n = 1)
Protocol (n = 1)
Duplicate (n = 1)
Not only low back pain (n = 64)
Full text trials assessed for
Eligibility

eligibility
(n = 470)

Trials included in
Included

quantitative synthesis
(n = 200)

Fig 1 Flow chart.

those that used less words than the word limit; those that exceeded multivariate regression models. The independent variables with
the word limit; and those published in a journal without abstract P<.20 in the univariate model were included in the final multi-
word limits. variate model by using backward elimination method, until all
independent variables achieved P<.05. Adjusted explained vari-
ance (adjusted R2), beta coefficient (b) and its 95% CIs were re-
Data analysis ported for each variable with possible association. Linearity was
To investigate the completeness of reporting and spin of infor- assessed by evaluation of linear relationship of the CONSORT-A
mation in the abstracts, the percentage of articles achieving each score with each independent variable using simple scatter plots.47
item of the CONSORT-A and the spin checklist were tabulated. Multicollinearity was tested with bivariate correlation analysis of
The mean and SD summary score were calculated for each the CONSORT-A score with each independent variable, and
checklist (CONSORT-A score and spin-abstract score). In order to coefficients of independent variables with r0.7 were not
investigate inconsistencies between abstract and full text, we used included in our linear regression model.48
paired t tests between the CONSORT-A scores with the Chi-square tests were used to evaluate the association between
CONSORTefull text scores and the spin-abstract scores with the trials with negative results and the presence of spin in the abstract
spinefull text scores, with P<.05. Agreement between the abstract (ie, classified as “yes”) for each item of the spin checklist. All 7
and full text for items 2-15 for the CONSORT-A (item 1 was items were evaluated to understand if individual items could have
excluded as it relates to the title) and all items from the spin different associations with negative results. SPSSc software
checklist were calculated using kappa coefficients.41 Kappa values version 20.0 was used for all analyses.
higher than 0.61 (ie, “substantial” to “almost perfect agree-
ment”)41 were the criterion for “acceptable” agreement between
abstract and full text. Results
Linear regression models were built to evaluate the association
between 10 trial and journal characteristics with the CONSORT-A The search strategy retrieved 537 potentially eligible trial reports
score and the spin-abstract score. We built both univariate and from the 25,956 existing trials indexed in the PEDro database on

www.archives-pmr.org
Abstracts of low back pain trials 5

Table 1 Descriptive data for the included trials (NZ200)


Characteristics Mean  SD No. of Articles (%)
Journal Citation Reports impact factor 2015 2.52.5 157 (78.5)
Journals without impact factor 43 (21.5)
Open access articles 115 (57.5)
Written in English 198 (99.0)
Written in Portuguese or Spanish 2 (1.0)
Continents
Europe 70 (35.0)
Asia 65 (32.5)
North America 33 (16.5)
South America 13 (6.5)
Africa 8 (4.0)
Oceania 11 (5.5)
Multicenter 17 (8.5)
Unicenter 183 (91.5)
Structured abstract 171 (85.5)
Unstructured abstract 29 (14.5)
Age of trial (y) 3.41.7
2010 28 (14.0)
2011 35 (17.5)
2012 36 (18.0)
2013 34 (17.0)
2014 29 (14.5)
2015 38 (19.0)
Statistically significant between-group differences for the primary outcome(s) 70 (35.0)
No statistically significant between-group differences for the primary outcome(s) 96 (48.0)
Did not report between-group differences for the primary outcome(s) 34 (17.0)
Number of words in the abstract 25867.3
Articles published in journals with abstract word limits 178 (89.0)
Abstracts that adhered to word limit 49 (24.5)
Abstracts that used less words than the word limit 64 (32.0)
Abstracts that exceeded the word limit 65 (32.5)
Abstracts that published in a journal without abstract word limits 22 (11.0)
Total PEDro score (/10) 5.81.6

February 1, 2016. Trials that were still in the recruitment stage, mean kappa  SD was 0.730.18; and for the items of the spin
protocols, duplicates, and those involving not only low back pain checklist the mean kappa was 0.670.11. We then resolved dis-
were excluded (nZ67) and are detailed in supplemental agreements by consensus.
appendix S1 (available online only at http://www.archives-pmr.
org/). From the remaining 470 eligible trials, we randomly Completeness of reporting of abstracts
selected a sample of approximately 40%, rounded up to 200 trials
(supplemental appendix S2, available online only at http://www. The mean CONSORT-A score  SD was 5.12.4 out of 15
archives-pmr.org/), as shown in the flow chart in figure 1. Jour- points. Table 2 presents the completeness of reporting for each
nals and their impact factors are described in supplemental item of the CONSORT-A. The items with the highest
appendix S3 (available online only at http://www.archives-pmr. completeness of reporting were specifying the objective
org/). Descriptive data for the 200 articles is presented in (97.0%), interventions (76.5%), and trial design (61.5%). The
table 1 and descriptive data of the 97 journals that published the items with the lowest completeness of reporting were specifying
included trials are presented in supplemental appendix S3. Most how participants were allocated to groups or randomization
trials were conducted in Europe or Asia and published in English. (2.0%), blinding (2.5%), and a result for each group and the
Most journals had an impact factor, more than half (51.5%) estimated effect size and its precision for the primary out-
endorsed CONSORT recommendations, and 38.1% were open comes (4.5%).
access. The methodologic quality of trials is presented in
supplemental appendix S4 (available online only at http://www. Spin of information in abstracts
archives-pmr.org/).
The agreement of data extraction between raters for both ab- The mean  SD spin-abstract score was 4.92.6 out of 7
stract and full text ranged from fair to almost perfect points, indicating that most abstracts overstated the results.
(see supplemental appendix S5, available online only at http:// Table 3 presents the each item of the spin checklist. The most
www.archives-pmr.org/). For the items of the CONSORT-A the common problems were failing to mention adverse events

www.archives-pmr.org
6 D.P. Nascimento et al

Table 2 Percentage of included trials achieving each item of the CONSORT-A in the abstract and full text (NZ200)
Fully Reported (%)
Item Description Abstract Full Text
1. Title Identification of the study as randomized 58.5
2. Trial design Description of the trial design 61.5 63.0
Methods
3. Participants Eligibility criteria for participants and the settings where the 44.5 89.5
data were collected
4. Interventions Interventions intended for each group 76.5 90.5
5. Objective Specific objective or hypothesis 97.0 95.5
6. Outcome Clearly defined primary outcome for this report 35.0 52.0
7. Randomization How participants were allocated to interventions 2.0 41.0
8. Blinding Whether or not participants, caregivers, and those assessing 2.5 15.5
the outcomes were blinded to group assignment
Results
9. Numbers randomized Number of participants randomized to each group 39.5 89.0
10. Numbers analyzed Number of participants analyzed in each group 10.5 88.0
11. Outcome For the primary outcome, a result for each group and the 4.5 32.5
estimated effect size and its precision
12. Harm Important adverse events or side effects 7.0 29.5
13. Conclusions General interpretation of the results 24.0 34.5
14. Trial registration Registration number and name of trial register 20.0 32.5
15. Funding Source of funding 23.5 68.5

(93.5% of abstracts), selective reporting of outcomes (73.0% of individual item of the CONSORT-A for the abstract and full
abstracts), and recommendation of a treatment (73.0% of ab- text sections are presented in table 2. No abstracts fully
stracts). Ninety-eight percent of the abstracts had at least 1 reported all 15 items (the highest number of items achieved
item of spin. was 13), while full reporting of full text occurred for 3.0%
of trials.
Abstracts inconsistencies with the full text Abstracts presented more spin of information than the full text
(PZ.01). The mean spin-abstract score was 4.92.6 out of 7 and
Abstracts were reported less completely than the full text mean spinefull text score was 3.72.9, with a mean difference of
(PZ.01). The mean CONSORT-A score  SD was 5.12.4 1.2 points (95% CI, 0.9-1.5). The ratings for the 7 items from the
out of 15 compared to a mean CONSORTefull text score of spin checklist ranged from fair to moderate agreement (mean
8.2 3.0, with a mean difference of -3.2 points (95% CI, kappa 0.490.11) between the abstract and full text
2.8-3.5). Agreement between the abstract and full text for (see supplemental appendix S6, available online only at http://
14 items from the CONSORT-A ranged from slight to www.archives-pmr.org/). Scoring for the individual items of the
moderate agreement (mean kappa 0.200.14) (supplemental spin checklist for both the abstract and full text are presented in
appendix S6). The percentage of trials achieving each table 3. Only 2.0% abstracts and 17.0% full texts scored zero for

Table 3 Percentage of included trials containing each item of the spin checklist in the abstract and full text (NZ200)
Yes (%) No (%)
Description of Each Item Abstract Full Text Abstract Full Text
1. Omission of primary outcomes 56.0 40.5 44.0 59.5
2. Fail to mention adverse events of interventions 93.5 68.5 6.5 31.5
3. Selective reporting of positive results and omission of negative 73.0 53.5 27.0 46.5
results of primary outcomes
4. Fail to report statistically nonsignificant primary outcomes 71.0 51.0 29.0 49.0
5. Focus on statistically significant outcomes other than the primary 62.5 49.0 37.5 51.0
6. Overenthusiastic interpretation of statistically nonsignificant primary 61.5 47.5 38.5 52.5
outcomes results as effective
7. Recommendation of a treatment without a clinically important effect 73.0 60.5 27.0 39.5
on primary outcomes
NOTE. Abstracts and full texts free of spin are represented in column “no”; columns “yes” represent the percentage of abstracts and full texts presenting
spin of information.

www.archives-pmr.org
Abstracts of low back pain trials 7

Table 4 Final multivariate models of associations between trial and journal characteristics with the CONSORT-A score and the spin-abstract
score
Multivariate Regression Multivariate Regression
Dependent Variable: CONSORT-A Score Dependent Variable: Spin-Abstract Score
Adjusted R2Z0.55 Adjusted R2Z0.17
ConstantZ3.74 (95% CI, 1.94-5.54) ConstantZ11.20 (95% CI, 9.28-13.11)
Independent Variables b 95% CI P b 95% CI P
Number of centers .86 -1.58 -2.77 to -0.39 .01*
Continent .83 .74
Language .23y .25y
Journal impact factor 0.12 0.01-0.23 .04* .07
Journal endorses CONSORT recommendations 0.76 0.16-1.36 .01* .26y
Number of words in the abstract 0.01 0.00-0.01 .01* -0.01 -0.01 to -0.00 .01*
Structured abstract .46 .58y
Total PEDro score 0.23 0.04-0.42 .02* -.39 -0.60 to -0.18 .01*
SPIN-Abstract score -0.47 -0.58 to -0.36 .01* N/A N/A N/A
Age of the article .83y .29y
Abbreviation: N/A, not applicable.
* Values with P<.05.
y
Eliminated in the univariate analysis, values with P<.20.

the spin-abstract and spinefull text scores, which means they were words in the abstract, higher total PEDro score, and lower spin-
free of spin. abstract score. Lower score of spin in abstracts (spin-abstract
score) was associated with multicenter trials, greater number of
words in the abstract, and higher total PEDro score.
Association of abstract completeness and spin with
trial and journal characteristics
Association of abstract spin with negative results
All variables were included into the linear regression model
exploring the association between abstract completeness and spin Table 5 presents the association between spin of information in the
with trial and journal characteristics. Simple scatter plots abstract and the presence of negative results for each item of spin
confirmed the linearity assumption and bivariate correlation co- checklist. We observed an association (P<.05) between negative
efficients were all less than 0.31 (ie, multicollinearity assumption). results for 3 of the 7 items: selectively reported positive results
The final multivariate model explained 55% (adjusted R2Z0.55) and ignored negative results of primary outcomes; fail to report
of the variance in completeness of reporting of abstracts and 17% primary outcomes statistically nonsignificant; and recommenda-
(adjusted R2Z0.17) of the variance in spin of information in ab- tion to use a treatment, if it does not have an important minimal
stracts (table 4). Higher completeness of abstracts (CONSORT-A clinical change. In other words, the presence of primary outcome
score) was associated with higher journal impact factor, journals negative results was associated with the presence of spin in
that endorse CONSORT recommendations, greater number of the abstract.

Table 5 Association of trials presenting negative results with percentage of abstracts indicating the presence of spin for each of the spin
checklist (NZ200)
Description of Each Item Negative Results, (%) c2 Values P Values
1. Omission of primary outcomes 37.0 0.57 .75
2. Fail to mention adverse events of interventions 60.5 1.31 .52
3. Selective reporting of positive results and omission of negative results of 50.0 15.34 .01*
primary outcomes
4. Fail to report statistically nonsignificant primary outcomes 50.0 15.40 .01*
5. Focus on statistically significant outcomes other than the primary 41.0 2.20 .33
6. Overenthusiastic interpretation of statistically nonsignificant primary 41.0 3.88 .15
outcomes results as effective
7. Recommendation of a treatment without a clinically important effect on 47.0 11.20 .01*
primary outcomes
NOTE. Negative results are the sum of percentage of articles with statistically nonsignificant between-group differences and those that did not report a
statistically significant between-group difference.
* Values with P<.05.

www.archives-pmr.org
8 D.P. Nascimento et al

Discussion publication officer; (2) developing core competencies for editors


and reviewers; (3) training for authors to write complete and
Reporting of abstracts is incomplete in general medicine jour- transparent papers; and (4) training for peer reviewers. These
nals,49 oncology,14 and infectious diseases12 (mean CONSORT-A training efforts could involve raising awareness of the academic
scoresZ12.1 measured on a 17-point scale, 9.9 measured on a community to the available guidelines for reporting studies, ethics
18-point scale, and 7.7 measured on a 17-point scale, respec- in publication, integrity and responsibility in research, as well as
tively). Our analysis of trials evaluating physiotherapy in- highlighting the issue of authors overstating their results.25
terventions for low back pain appears to have relatively lower Authors could also be encouraged to write the abstract after the
completeness of reporting in the abstract (mean CONSORT-A full text has been finalized. Programs with this type of content that
scoreZ5.1). The description of items related to randomization, target authors, journal editors, and reviewers could and should be
blinding, results of primary outcomes, harms, and trial registration implemented.
were particularly problematic. Our analysis of article characteristics associated with better
The presence of spin of information in abstracts is evident in abstract reporting and avoiding spin in abstracts identified vari-
general medicine, as one study reported 41% of abstracts with at ables that predict better reporting and interpretation. Higher
least one type of spin27 whereas other authors found that 68.1% completeness of reporting was associated with publication in
had spin in at least 1 section of the abstract.25 The abstracts of trial journals with higher impact factors and that endorse CONSORT
reports in low back pain appear to contain more spin of infor- recommendations, greater number of words in the abstract, higher
mation (98.0% of abstracts have at least 1 item of spin) than in total PEDro score, and a lower spin-abstract score. Additionally,
other areas of health care. Authors of analyzed trial reports tended avoiding spin was also related to conducting the trial in more than
to either omit nonsignificant results for primary outcomes or one center, which may be explained to the fact that different in-
interpret them as beneficial, which can impact health care pro- stitutions are involved in the writing process and consequently the
fessionals’ interpretation of abstract results.33 manuscript is peer reviewed by a broader group of researchers.
Consistency between abstracts and the full text is far from Two possible strategies involve changing a journal’s editorial
perfect in the field of pharmacy (61% classified as inconsistent policies to increase the number of words permitted in the abstract
with the full text),23 sports injury prevention (80% had at least 1 to at least 350 words (500 words ideally) and endorsing (and
major inconsistency with the full text),17 psychology (average of using) the CONSORT recommendations, including the extension
13% inconsistent abstracts compared to the full text),24 and for abstracts. Recommendations on using journal impact factor as
medicine (53% had data inconsistencies compared to the full reference for publication have been discussed since 2005 and have
text).22 Using a differential approach, we have determined that been considered to be partially inappropriate.58
abstracts of trials evaluating physiotherapy interventions for low
back pain presented several inconsistencies with their full texts.
Important to note that these studies used different statistical
Study strengths and limitations
approaches, therefore, a direct comparison of our results with the One of the strengths of this study is the representative sample of
existing literature is not straightforward. 42% of all trials evaluating physiotherapy interventions for low
To simplify the evaluation of completeness of reporting and back pain published in 2010 to 2015. Additionally, we used the
spin, we generated summary scores for the CONSORT-A and the CONSORT-A7 to evaluate completeness of reporting. This
spin checklist, which quantified these constructs as single, checklist has been used previously to compare conference
dependent variables. Although this scale is not fully validated,50 abstracts with the abstract subsequently used in the full publica-
the spin checklist presented moderate to almost perfect agree- tion of the trial17 and seems to be a good measurement tool to
ment between raters. The use of summary scores will facilitate compare the level of agreement between abstract and full text in
future comparisons between different areas of health care and our study. Furthermore, the assessment of spin has been consid-
evaluation of strategies to improve reporting and reduce spin. ered to be somewhat subjective and difficult to evaluate.50 To
Spin of information can negatively impact health care as address this concern, we used a recent developed spin checklist.33
abstracts are commonly used by health care professionals to In the attempt to limit subjectivity, we used 2 reviewers to inde-
inform treatment decisions33 and are widely disseminated in the pendently score the included trials, with disagreements resolved
press and news.27 Spin can happen for many reasons, including by consensus. A limitation of this study was that abstracts not
not understanding scientific standards, young researchers copying clearly defining the primary outcomes were automatically classi-
previous bad practices, unconscious bias, intentional attempts to fied as containing spin of information, as most of the items of the
influence the readers,51 and academic press releases to attract spin checklist relate to the primary outcomes. In order not to
readers’ attention.27,29-32 In addition, authors favoring or inter- overestimate spin, if a trial only reported 1 or 2 outcomes but did
preting results as effective, when those are not statistically sig- not explicitly state that the outcomes were “primary,” we
nificant, may induce journal reviewers and editors to accept an considered them to be the primary outcomes when applying the
article for publication.52 Whatever the cause of spin, this misin- spin checklist. Another limitation relates to the evaluation of
terpretation can potentially damage clinical practice and the agreement between raters, which did not take into account the
integrity of research.53,54 interdependency of the items in the spin checklist.
It seems that health care journals’ editors and reviewers are
either unaware of the importance of avoiding abstracts in-
consistencies with the full text55 or not sufficiently trained to
detect methodologic or reporting mistakes related to abstracts.56
Conclusions
Consequently, Moher and Altman57 described 4 actions to Similar to other health care trials, the abstracts of randomized
improve the completeness, transparency, integrity, and value of controlled trials evaluating physiotherapy interventions for low
abstracts and papers published: (1) employment of a professional back pain are incompletely reported, contain spin of information,

www.archives-pmr.org
Abstracts of low back pain trials 9

and are inconsistent with the full text. Authors, reviewers, and 7. Hopewell S, Clarke M, Moher D, et al. CONSORT for reporting
journal editors need to improve the completeness of reporting and randomized controlled trials in journal and conference abstracts:
reduce spin of results in abstracts. In order to do so, we encourage explanation and elaboration. PLoS Med 2008;5:201-9.
journal editors to consider changing some editorial policies, such 8. Dijkers MP. Searching the literature for information on traumatic
spinal cord injury: the usefulness of abstracts. Spinal Cord 2003;41:
as increasing the number of words allowed in the abstract and
76-84.
offering adequate training to improve peer reviewers attention to 9. Chhapola V, Tiwari S, Brar R, Kanwal SK. Reporting quality of trial
abstracts (in terms of reporting, interpretation of results, and abstracts-improved yet suboptimal: a systematic review and meta-
consistency of data between abstract and full text). Journal editors analysis. J Evid Based Med 2018;11:89-94.
and reviewers should jointly be responsible for improving research 10. Song SY, Kim B, Kim I, et al. Assessing reporting quality of ran-
integrity, transparency, and ethics in the publication process. domized controlled trial abstracts in psychiatry: adherence to CON-
Finally, authors of trials should carefully choose journals with SORT for abstracts: a systematic review. PLoS One 2017;12:
strict methodologic and reporting standards for publication, as e0187807.
well as writing the abstract only when the full text has 11. Li G, Abbade LPF, Nwosu I, et al. A scoping review of comparisons
been finalized. between abstracts and full reports in primary biomedical research.
BMC Med Res Methodol 2017;17:181.
12. Bigna JJ, Noubiap JJ, Asangbeh SL, et al. Abstracts reporting of
HIV/AIDS randomized controlled trials in general medicine and in-
Suppliers fectious diseases journals: completeness to date and improvement in
the quality since CONSORT extension for abstracts. BMC Med Res
a. Microsoft Excel; Microsoft Corporation. Methodol 2016;16:138.
13. Ghimire S, Kyung E, Kang W, Kim E. Assessment of adherence to the
b. Journal Citation Reports; Clarivate Analytics.
CONSORT statement for quality of reports on randomized controlled
c. SPSS software v. 20; IBM Corp. trial abstracts from four high-impact general medical journals. Trials
2012;13:77.
14. Ghimire S, Kyung E, Lee H, Kim E. Oncology trial abstracts showed
suboptimal improvement in reporting: a comparative before-and-after
Keywords evaluation using CONSORT for abstract guidelines. J Clin Epidemiol
2014;67:658-66.
Abstracting and indexing as topic; Data accuracy; Low back pain;
15. Guo JW, Iribarren SJ. Reporting quality for abstracts of randomized
Randomized controlled trials as topic; Rehabilitation controlled trials in cancer nursing research. Cancer Nurs 2014;37:
436-44.
16. Wang L, Li Y, Li J, et al. Quality of reporting of trial abstracts needs to
Corresponding author be improved: using the CONSORT for abstracts to assess the four
leading Chinese medical journals of traditional Chinese medicine.
Dafne P. Nascimento, PhD, Masters and Doctoral Programs in Trials 2010;11:75.
Physical Therapy, Universidade Cidade de Sao Paulo, Rua Cesario 17. Yoon U, Knobloch K. Assessment of reporting quality of conference
Galeno 448, Tatuape, Sao Paulo, SP e Brazil, CEP 03071-000. E- abstracts in sports injury prevention according to CONSORT and
mail address: dafnepn@yahoo.com.br. STROBE criteria and their subsequent publication rate as full papers.
BMC Med Res Methodol 2012;12:47.
18. Lai R, Chu R, Fraumeni M, Thabane L. Quality of randomized
controlled trials reporting in the primary treatment of brain tumors. J
Acknowledgment Clin Oncol 2006;24:1136-44.
19. Peron J, Pond GR, Gan HK, et al. Quality of reporting of modern
We thank all authors and funders of the randomized controlled randomized controlled trials in medical oncology: a systematic review.
trial studies that contributed data to the present study. J Natl Cancer Inst 2012;104:982-9.
20. Shiwa SR, Moseley AM, Maher CG, Pena Costa LO. Language of
publication has a small influence on the quality of reports of controlled
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Abstracts of low back pain trials


Supplemental Appendix S1
Excluded Trials

Year Journal Title Reason for exclusion


2010 Physiotherapy Theory and Practice The use of sensory electrical stimulation for pressure ulcer prevention Not low back pain, pressure ulcer.
2010 Academic Emergency Medicine Heat or cold packs for neck and back strain: a randomized controlled trial of efficacy Not only low back pain, neck and thoracic
spine.
2010 BMC Musculoskeletal Disorders The long-term effects of naprapathic manual therapy on back and neck pain - results from a Not only low back pain, neck and thoracic
pragmatic randomized controlled trial spine.
2010 BMC Musculoskeletal Disorders The long-term effects of naprapathic manual therapy on back and neck pain - results from a Not only low back pain, neck and thoracic
pragmatic randomized controlled trial spine.
2010 Pain Medicine Predictors of pain outcomes in patients with chronic musculoskeletal pain co-morbid with Not low back pain, musculoskeletal pain
depression: results from a randomized controlled trial in general.
2010 Physical Therapy Effects of traditional sit-up training versus core stabilization exercises on short-term Not low back pain, musculoskeletal
musculoskeletal injuries in US army soldiers: a cluster randomized trial injuries in general.
2011 Physiotherapy Effect of a high-density foam seating wedge on back pain intensity when used by 14 to Not only low back pain, neck and thoracic
16-year-old school students: a randomised controlled trial spine.
2011 BMC Public Health Effects on musculoskeletal pain, work ability and sickness absence in a 1-year randomised Not low back pain, musculoskeletal pain
controlled trial among cleaners in general.
2011 Pain Practice Comparison of acupuncture to injection for myofascial trigger point pain Not low back pain, myofascial trigger
point pain.
2011 The Journal of Rheumatology Rehabilitation treatment in patients with ankylosing spondylitis stabilized with tumor Not low back pain, ankylosing spondylitis.
necrosis factor inhibitor therapy. A randomized controlled trial
2011 Revista Brasileira de Fisioterapia Effects of two physical therapy interventions in patients with chronic non-specific low back Partial analysis, study still ongoing.
[Brazilian Journal of Physical Therapy] pain: feasibility of a randomized controlled trial
2011 Pain Impact of biomedical and biopsychosocial training sessions on the attitudes, beliefs, and Not low back pain, physiotherapists
recommendations of health care providers about low back pain: a randomised clinical beliefs.
trial
2011 Italian Journal of Physiotherapy Effect of a physiotherapy program in the management of musculoskeletal disorders in Not low back pain, musculoskeletal
hairdressers: a randomized controlled trial injuries in general.
2011 Journal of Bodywork and Movement Fascial release effects on patients with non-specific cervical or lumbar pain Not only low back pain, neck and thoracic
Therapies spine.
2011 Turkish Journal of Rheumatology Long-term effects of comprehensive inpatient rehabilitation on function and disease Not low back pain, chronic rheumatoid
activity in patients with chronic rheumatoid arthritis and ankylosing spondylitis arthritis and ankylosing spondylitis.
2011 Scandinavian Journal of Work, Kettlebell training for musculoskeletal and cardiovascular health: a randomized controlled Not low back pain, musculoskeletal pain
Environment & Health trial in general.
2011 Journal of Rehabilitation Medicine Efficacy of rehabilitation for patients with ankylosing spondylitis: comparison of a four- Not low back pain, ankylosing spondylitis.
week rehabilitation programme in a Mediterranean and a Norwegian setting
(continued on next page)

10.e1
10.e2
(continued )
Year Journal Title Reason for exclusion
2011 Scandinavian Journal of Work, The effectiveness of participatory ergonomics to prevent low-back and neck pain - results Not only low back pain, neck and thoracic
Environment & Health of a cluster randomized controlled trial spine.
2011 European Spine Journal Long-term effectiveness of a back education programme in elementary school children: an Not only low back pain, neck and thoracic
8-year follow-up study spine.
2011 Journal of Bodywork and Movement The immediate effects of traditional Thai massage on heart rate variability and stress- Not only low back pain, neck and thoracic
Therapies related parameters in patients with back pain associated with myofascial trigger points spine.
2011 Indian Journal of Physiotherapy and Effectiveness of coccygeal manipulation in coccydynia: a randomized control trial Duplicate.
Occupational Therapy
2012 Disability and Rehabilitation Effectiveness of different interventions using a psychosocial subgroup assignment in Not only low back pain, neck and thoracic
chronic neck and back pain patients: a 10-year follow-up spine.
2012 Journal of Athletic Training Lumbopelvic joint manipulation and quadriceps activation of people with patellofemoral Not low back pain, patellofemoral pain
pain syndrome syndrome.
2012 Rheumatology International Effect of Pilates training on people with ankylosing spondylitis Not low back pain, ankylosing spondylitis.
2012 Medical Science Monitor The objective evaluation of effectiveness of manual treatment of spinal function Not only low back pain, neck and thoracic
disturbances spine.
2012 Iranian Red Crescent Medical Journal A randomized clinical trial of fibromyalgia treatment with acupuncture compared with Not low back pain, fibromyalgia.
fluoxetine
2012 Clinical Cases in Mineral and Bone A randomized control trial on the effectiveness of osteopathic manipulative treatment in Not low back pain, osteoporosis.
Metabolism reducing pain and improving the quality of life in elderly patients affected by
osteoporosis
2012 The American Journal of Chinese Medicine Randomized controlled pilot study: pain intensity and pressure pain thresholds in patients Not only low back pain, neck and thoracic
with neck and low back pain before and after traditional East Asian “Gua Sha” therapy spine.
2012 Pain A randomized controlled evaluation of an online chronic pain self management program Not low back pain, chronic pain in
general.
2012 Pain Is there a potential role for attention bias modification in pain patients? Results of 2 Not low back pain, acute and chronic pain
randomised, controlled trials in general.
2012 Journal of Bodywork and Movement The effectiveness of the Pilates method: reducing the degree of non-structural scoliosis, Not only low back pain, neck and thoracic
Therapies and improving flexibility and pain in female college students spine.
2012 Journal of Physical Therapy Science Stretching versus mechanical traction of the spine in treatment of idiopathic scoliosis Not low back pain, scoliosis in the spine.
2013 BMC Musculoskeletal Disorders Implementation of specific strength training among industrial laboratory technicians: Not only low back pain, neck and upper
long-term effects on back, neck and upper extremity pain limbs.
2013 Journal of Rehabilitation Medicine A three-week multidisciplinary in-patient rehabilitation programme had positive long-term Not low back pain, ankylosing spondylitis.
effects in patients with ankylosing spondylitis: randomized controlled trial
2013 Journal of Strength & Conditioning Effect of specific resistance training on musculoskeletal pain symptoms: dose-response Not low back pain, musculoskeletal pain
Research relationship in general.
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D.P. Nascimento et al
2013 Turkish Journal of Rheumatology A comparison of the efficacy of dry needling, lidocaine injection, and oral flurbiprofen Not low back pain, myofascial pain
treatments in patients with myofascial pain syndrome: a double-blind (for injection syndrome.
groups only), randomized clinical trial
2013 Spine Short term usual chiropractic care for spinal pain: a randomised controlled trial Not only low back pain, neck and thoracic
spine.
(continued on next page)
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Abstracts of low back pain trials


(continued )
Year Journal Title Reason for exclusion
2013 Applied Ergonomics Office ergonomics training and a sit-stand workstation: effects on musculoskeletal and Not low back pain, musculoskeletal pain
visual symptoms and performance of office workers in general.
2013 Clinical Rehabilitation Supervised training and home-based rehabilitation in patients with stabilized ankylosing Not low back pain, ankylosing spondylitis.
spondylitis on TNF inhibitor treatment: a controlled clinical trial with a 12-month
follow-up
2013 Annals of Agricultural & Environmental Physical therapy versus medical treatment of musculoskeletal disorders in dentistry - a Not low back pain, musculoskeletal pain
Medicine randomised prospective study in general.
2013 Arthritis Care & Research Effect of cardiovascular training on fitness and perceived disease activity in people with Not low back pain, ankylosing spondylitis.
ankylosing spondylitis
2013 Spine Outcomes of Usual Chiropractic Harm (OUCH) randomised controlled trial of adverse events Protocol.
2013 Clinical and Experimental Rheumatology Outcome of an education and home-based exercise programme for patients with ankylosing Not low back pain, ankylosing spondylitis.
spondylitis: a nationwide randomized study
2013 Swiss Medical Weekly Culturally sensitive group therapy for Turkish patients suffering from chronic pain: a Not low back pain, chronic pain in
randomised controlled intervention trial general.
2013 Rheumatology International The effects of combined spa therapy and rehabilitation on patients with ankylosing Not low back pain, ankylosing spondylitis.
spondylitis being treated with TNF inhibitors
2013 The Journal of Orthopaedic and Sports Efficacy of thrust and non-thrust manipulation and exercise with or without the addition of Not low back pain, ankle sprain.
Physical Therapy myofascial therapy for the management of acute post-inversion ankle sprain: a
randomized clinical trial
2013 Spine A randomized trial of balloon kyphoplasty and non-surgical management for treating acute Not low back pain, kyphosis correction.
vertebral compression fractures: vertebral body kyphosis correction and surgical
parameters
2014 Rheumatology International Effects of Pilates, McKenzie and Heckscher training on disease activity, spinal motility and Not low back pain, ankylosing spondylitis.
pulmonary function in patients with ankylosing spondylitis: a randomized controlled
trial
2014 Journal of Physical Activity & Health Evaluation of Active Living Every Day in adults with arthritis Not low back pain, arthritis.
2014 Spine The effect of work-focused rehabilitation among patients with neck and back pain: a Not only low back pain, neck and thoracic
randomised controlled trial spine.
2014 Fisioterapia em Movimento [Physical Impact of dry needling and ischemic pressure in the myofascial syndrome: controlled Not low back pain, myofascial pain
Therapy in Movement] clinical trial syndrome.
2014 The Clinical Journal of Pain Paraspinal stimulation combined with trigger point needling and needle rotation for the Not low back pain, myofascial pain
treatment of myofascial pain: a randomized sham-controlled clinical trial syndrome.
2014 Manual Therapy Manual therapy directed at the knee or lumbopelvic region does not influence quadriceps Not low back pain, knee injury.
spinal reflex excitability
2014 BMC Musculoskeletal Disorders Adverse events after manual therapy among patients seeking care for neck and/or back Not only low back pain, neck and thoracic
pain: a randomized controlled trial spine.
2014 International Journal of Therapeutic Relief from back pain through postural adjustment: a controlled clinical trial of the Not only low back pain, musculoskeletal
Massage and Bodywork immediate effects of muscular chains therapy (MCT) pain in the spine.
2014 PLoS ONE Efficacy of high intensity exercise on disease activity and cardiovascular risk in active axial Not low back pain, axial spondyloarthritis.
spondyloarthritis: a randomized controlled pilot study

10.e3
(continued on next page)
10.e4
(continued )
Year Journal Title Reason for exclusion
2014 Health Psychology Can we improve cognitive-behavioral therapy for chronic back pain treatment engagement Not only low back pain, neck and thoracic
and adherence? A controlled trial of tailored versus standard therapy spine.
2014 Rheumatology International Effect of aquatic exercise on ankylosing spondylitis: a randomized controlled trial Not low back pain, ankylosing spondylitis.
2014 Acupuncture in Medicine Efficacy and safety of auriculopressure for primary care patients with chronic non-specific Not only low back pain, neck and thoracic
spinal pain: a multicentre randomised controlled trial spine.
2015 Clinical Rehabilitation Inspiratory muscle training improves aerobic capacity and pulmonary function in patients Not low back pain, ankylosing spondylitis.
with ankylosing spondylitis: a randomized controlled study
2015 Occupational Therapy International Effect of an exercise programme for the prevention of back and neck pain in poultry Not only low back pain, neck and thoracic
slaughterhouse workers spine.
2015 European Journal of Physical and McKenzie training in patients with early stages of ankylosing spondylitis: results of a 24- Not low back pain, ankylosing spondylitis.
Rehabilitation Medicine week controlled study
2015 Medicina Clinica Efectos de un programa de ejercicio fisico y relajacion en el medio acuatico en pacientes Not low back pain, spondyloarthritis.
con espondiloartritis: ensayo clinico aleatorizado
2015 Scandinavian Journal of Work, Effect of workplace- versus home-based physical exercise on musculoskeletal pain among Not low back pain, musculoskeletal pain
Environment & Health healthcare workers: a cluster randomized controlled trial in general.
2015 BMC Musculoskeletal Disorders Change in pain, disability and influence of fear-avoidance in a work-focused intervention Not only low back pain, neck and thoracic
on neck and back pain: a randomized controlled trial spine.
2015 Evidence-Based Complementary and BEMER therapy combined with physiotherapy in patients with musculoskeletal diseases: a Not low back pain, musculoskeletal
Alternative Medicine randomised, controlled double blind follow-up pilot study injuries.
2015 Scientific Reports Validation of placebo in a manual therapy randomized controlled trial Not low back pain, migraines.
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D.P. Nascimento et al
Abstracts of low back pain trials 10.e5

Supplemental Appendix S2 17. Cambron JA, Schneider M, Dexheimer JM, Iannelli G, Chang M,
Terhorst L, et al. A pilot randomized controlled trial of flexion-
distraction dosage for chiropractic treatment of lumbar spinal steno-
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Abstracts of low back pain trials 10.e11

Supplemental Appendix S3
Percentage of trials per journal, 2015 impact factor, CONSORT
recommendations endorsement and open access journals (nZ200).

Impact Endorses CONSORT Open Access


Item Journal Percentage (%) Factor 2015 Recommendations Journals
1 Acta Anaesthesiologica Taiwanica 0.5 Not reported Yes Yes
2 Acta Clinica Croatica 0.5 0,412 No No
3 Acupuncture in Medicine 1.0 1,592 Yes No
4 American Journal of Physical Medicine & Rehabilitation 0.5 2,064 Yes No
5 An International Quarterly Journal of Research in Ayurveda 0.5 Not reported Yes Yes
6 Annals of Family Medicine 0.5 5,087 Yes Yes
7 Annals of Internal Medicine 1.0 16,440 Yes No
8 Annals of Rehabilitation Medicine 1.0 Not reported Yes Yes
9 Archives of Internal Medicine 0.5 Not reported Yes Yes
10 Archives of Physical Medicine and Rehabilitation 2.5 3,045 Yes No
11 BMC Medicine 1.5 8,005 Yes Yes
12 BMC Musculoskeletal Disorders 2.0 1,684 Yes Yes
13 BMC Pregnancy and Childbirth 0.5 2,180 Yes Yes
14 British Journal of Sports Medicine 1.0 6,724 No No
15 British Medical Journal 0.5 19,697 Yes No
16 Caspian Journal of Internal Medicine 0.5 Not reported No Yes
17 Chinese Medicine 0.5 1,580 Yes Yes
18 Chiropractic & Manual Therapies 0.5 Not reported Yes Yes
19 Chung I Tsa Chih Ying Wen Pan [Journal of Traditional 0.5 1,023 Yes Yes
Chinese Medicine]
20 Clinical Neurology and Neurosurgery 0.5 1,198 No No
21 Clinical Rehabilitation 2.5 2,403 No No
22 Clinical Rheumatology 0.5 2,042 No No
23 Clinics 0.5 1,328 No Yes
24 Disability and Rehabilitation 0.5 1,919 No No
25 Ergonomics 0.5 1,449 No No
26 European Journal of Pain 1.0 2,900 Yes No
27 European Journal of Physical and Rehabilitation Medicine 2.0 2,063 Yes Yes
28 European Spine Journal 1.5 2,132 No No
29 Evidence-Based Complementary and Alternative Medicine 2.0 1,931 No Yes
30 Family Practice 0.5 2,022 Yes No
31 Fisioterapia em movimento 0.5 Not reported No No
32 Geriatric Orthopaedic Surgery & Rehabilitation 0.5 Not reported Yes Yes
33 Health Technology Assessment 0.5 4,058 Yes Yes
34 Indian Journal of Physiotherapy and Occupational Therapy 3.5 1,166 No No
35 International Journal of Clinical and Experimental Medicine 0.5 1,075 No Yes
36 International Journal of Clinical Practice 0.5 2,226 Yes No
37 International Journal of Gynaecology and Obstetrics 0.5 1,674 Yes No
38 International Journal of Neurology and Neurosurgery 0.5 Not reported No No
39 International Journal of Nursing Studies 0.5 3,561 Yes No
40 International Journal of Osteopathic Medicine 0.5 0,509 Yes Yes
41 International Journal of Pharma and Bio Sciences 0.5 Not reported No Yes
42 International Journal of Physiotherapy and Research 0.5 Not reported No Yes
43 International Journal of Rheumatic Diseases 0.5 1,914 No No
44 International Journal of Sports Physical Therapy 0.5 Not reported Yes Yes
45 Isokinetics and Exercise Science 0.5 0,357 No No
46 Joint, Bone, Spine 0.5 Not reported No No
47 Journal of Acupuncture and Tuina Science 0.5 Not reported No No
48 Journal of Advanced Nursing 0.5 1,917 Yes No
49 Journal of Alternative & Complementary Medicine 1.0 1,395 Yes No
50 Journal of Back and Musculoskeletal Rehabilitation 3.5 0,956 No No
(continued on next page)

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10.e12 D.P. Nascimento et al

(continued )
Impact Endorses CONSORT Open Access
Item Journal Percentage (%) Factor 2015 Recommendations Journals
51 Journal of Bodywork and Movement Therapies 1.5 Not reported No No
52 Journal of Clinical Nursing 0.5 1,384 Yes No
53 Journal of Cognitive and Behavioral Psychotherapies 0.5 Not reported No No
54 Journal of Manipulative and Physiological Therapeutics 3.5 1,329 Yes No
55 Journal of Medical Internet Research 0.5 4,532 Yes Yes
56 Journal of Musculoskeletal Research 1.0 Not reported No No
57 Journal of Physical Therapy Science 5.5 Not reported No Yes
58 Journal of Physiotherapy 1.0 4,000 Yes Yes
59 Journal of Rehabilitation Medicine 2.5 1,595 Yes Yes
60 Journal of Science and Medicine in Sport 0.5 3,756 No No
61 Journal of Sport Rehabilitation 0.5 1,612 No No
62 Lasers in Medical Science 1.0 2,461 No No
63 Manual Therapy 2.0 1,869 Yes No
64 Medical Science Monitor 1.0 1,405 No No
65 Medicine and Science in Sports and Exercise 0.5 4,041 No No
66 Military Medicine 0.5 0,969 Yes No
67 Neurosciences 0.5 0,541 Yes Yes
68 New Zealand Journal of Physiotherapy 0.5 Not reported No No
69 Nigerian Journal of Clinical Practice 0.5 0,524 Yes Yes
70 Pain 1.5 5,557 Yes No
71 Pain Medicine 0.5 2,324 No No
72 Pain Practice 0.5 2,317 Yes No
73 Photomedicine and Laser Surgery 0.5 1,631 No No
74 Physical Therapy 4.0 2,779 Yes No
75 Physiotherapy 0.5 1,814 Yes No
76 PLoS ONE 0.5 3,057 Yes Yes
77 PM&R 1.0 1,655 Yes No
78 Psychology, Health & Medicine 0.5 1,347 No No
79 Rawal Medical Journal 0.5 Not reported No Yes
80 Revista de Investigacion Clinica 0.5 0,477 No No
81 Revista Paulista de Medicina [Sao Paulo Medical Journal] 0.5 0,955 Yes Yes
82 Rheumatology International 0.5 1,702 Yes No
83 South African Journal of Physiotherapy 1.0 Not reported No Yes
84 Southern Medical Journal 0.5 0,882 No No
85 Spine 8.0 2,439 Yes No
86 Swiss Medical Weekly 0.5 1,549 No Yes
87 The American Journal of the Medical Sciences 0.5 1,757 No No
88 The Clinical Journal of Pain 2.0 2,712 No No
89 The Journal of International Medical Research 1.0 1,431 Yes No
90 The Journal of Manual & Manipulative Therapy 0.5 Not reported No Yes
91 The Journal of the American Medical Association 0.5 Not reported Yes No
92 The Journal of the American Osteopathic Association 1.0 Not reported No No
93 The Spine Journal 2.5 2,660 Yes No
94 The West Indian Medical Journal 0.5 Not reported No No
95 Turk Fizyoterapi ve Rehabilitasyon Dergisi [Turkish Journal 0.5 Not reported No Yes
of Physiotherapy and Rehabilitation]
96 Turkish Neurosurgery 0.5 0,508 Yes Yes
97 Turkiye Fiziksel Tip ve Rehabilitasyon Dergisi 0.5 Not reported No Yes
[Turkish Journal of
Physical Medicine and Rehabilitation]

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Abstracts of low back pain trials 10.e13

Supplemental Appendix S4
Methodologic quality of the 200 trials, measured by the PEDro
scale [44, 45]. Data presented for the total PEDro score.

First Author Year Journal Total PEDro Score 0/10


Aboagye 2015 Journal of Rehabilitation Medicine 6
Alayat 2014 Lasers in Medical Science 5
Albaladejo 2010 Spine 7
Albert 2012 Spine 7
Aleksiev 2014 Spine 4
Alp 2014 Turkish Journal of Physical Medicine and Rehabilitation 6
Aluko 2013 Journal of Manipulative and Physiological Therapeutics 7
Apeldoorn 2012 European Spine Journal 7
Apeldoorn 2012 Spine 8
Bajaj 2010 Indian Journal of Physiotherapy and Occupational Therapy 5
Becker 2012 Spine 7
Bello 2010 Journal of Musculoskeletal Research 4
Bi 2013 The Journal of International Medical Research 7
Bronfort 2014 Annals of Internal Medicine 8
Bronfort 2011 The Spine Journal 8
Bruce-Low 2012 Ergonomics 5
Cambron 2014 Journal of Manipulative and Physiological Therapeutics 6
Campello 2012 Military Medicine 6
Cecchi 2012 European Journal of Physical and Rehabilitation Medicine 4
Chan 2011 Archives of Physical Medicine and Rehabilitation 7
Chen 2015 Clinical Neurology and Neurosurgery 6
Chen 2012 Acupuncture in Medicine 8
Chiauzzi 2010 Pain Medicine 6
Cho 2015 Journal of Physical Therapy Science 4
Christiansen 2010 Pain 6
Chuang 2012 Spine 5
Cramer 2013 Journal of Manipulative and Physiological Therapeutics 5
Cruz-Diaz 2015 Disability and Rehabilitation 8
Cuesta-Vargas 2012 Clinical Rheumatology 8
Cuesta-Vargas 2011 American Journal of Physical Medicine & Rehabilitation 6
de Oliveira 2013 Physical Therapy 8
del Pozo-Cruz 2013 Psychology, Health & Medicine 4
del Pozo-Cruz 2013 Clinical Rehabilitation 5
del Pozo-Cruz 2011 Journal of Rehabilitation Medicine 7
del Pozo-Cruz 2012 Journal of Rehabilitation Medicine 7
Demir 2014 European Journal of Physical and Rehabilitation Medicine 4
Dogan 2011 Southern Medical Journal 5
Dougherty 2014 Geriatric Orthopaedic Surgery & Rehabilitation 8
Eadie 2013 Archives of Physical Medicine and Rehabilitation 7
Ebadi 2012 BMC Musculoskeletal Disorders 8
Facci 2011 Sao Paulo Medical Journal 7
Fatemi 2015 Journal of Back and Musculoskeletal Rehabilitation 4
Ferrari 2015 Rheumatology International 5
Fiore 2011 European Journal of Physical and Rehabilitation Medicine 4
Flack 2015 BMC Pregnancy and Childbirth 6
Ford 2015 British Journal of Sports Medicine 6
Franca 2012 Journal of Manipulative and Physiological Therapeutics 4
Franca 2010 Clinics 7
Fritz 2015 The Journal of the American Medical Association 8
Froholdt 2011 The Spine Journal 6
Ganesh 2015 Journal of Back and Musculoskeletal Rehabilitation 5
(continued on next page)

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10.e14 D.P. Nascimento et al

(continued )
First Author Year Journal Total PEDro Score 0/10
Garcia 2013 Physical Therapy 6
Garcia 2015 Physical Therapy 6
George 2011 BMC Medicine 6
Grunnesjo 2011 Clinical Rehabilitation 7
Gunay 2014 Turkish Journal of Physiotherapy and Rehabilitation 7
Gupta 2012 Indian Journal of Physiotherapy and Occupational Therapy 2
Guthrie 2012 Journal of Sport Rehabilitation 6
Gutke 2010 Journal of Rehabilitation Medicine 6
Haakstad 2015 Journal of Rehabilitation Medicine 7
Haas 2014 The Spine Journal 5
Han 2011 Journal of Physical Therapy Science 4
Hartvigsen 2010 BMC Musculoskeletal Disorders 7
Hasegawa 2014 Acupuncture in Medicine 8
Hellum 2011 British Medical Journal 8
Henchoz 2010 Spine 6
Henchoz 2010 Swiss Medical Weekly 7
Henry 2014 The Spine Journal 6
Hidalgo 2015 Journal of Manipulative and Physiological Therapeutics 8
Hill 2015 Physical Therapy 6
Hoffman 2011 Manual Therapy 5
Homayouni 2015 Journal of Musculoskeletal Research 6
Hsieh 2014 Lasers in Medical Science 9
Huber 2011 Isokinetics and Exercise Science 6
Hugli 2015 Journal of Bodywork and Movement Therapies 7
Hurley 2015 Pain 6
Hwang 2013 Journal of Physical Therapy Science 4
Jacobson 2015 Evidence-Based Complementary and Alternative Medicine 7
Jain 2012 Indian Journal of Physiotherapy and Occupational Therapy 3
Jaromi 2012 Journal of Clinical Nursing 6
Javadian 2015 Caspian Journal of Internal Medicine 5
Javadian 2012 Journal of Back and Musculoskeletal Rehabilitation 4
Jensen 2012 BMC Musculoskeletal Disorders 5
Jensen 2015 Chiropractic & Manual Therapies 5
Jensen 2012 BMC Medicine 7
Johnsen 2014 Spine 5
Kamali 2012 Journal of Bodywork and Movement Therapies 6
Kawu 2011 Nigerian Journal of Clinical Practice 5
Kendall 2015 Journal of Science and Medicine in Sport 8
Khatri 2010 Indian Journal of Physiotherapy and Occupational Therapy 3
Kim 2015 International Journal of Osteopathic Medicine 8
Kluge 2011 International Journal of Gynaecology and Obstetrics 7
Kordi 2013 Journal of Back and Musculoskeletal Rehabilitation 5
Krammer 2015 New Zealand Journal of Physiotherapy 6
Kumar 2011 International Journal of Neurology and Neurosurgery 5
Lamb 2010 Health Technology Assessment 5
Lara-Palomo 2013 Clinical Rehabilitation 7
Lawand 2015 Joint, Bone, Spine 8
Learman 2013 Journal of Manipulative and Physiological Therapeutics 5
Lee 2015 Journal of Physical Therapy Science 5
Lee 2014 Journal of Physical Therapy Science 5
Lewis 2011 Journal of Physiotherapy 7
Licciardone 2013 The Journal of the American Osteopathic Association 7
Licciardone 2012 The Journal of the American Osteopathic Association 4
Licciardone 2013 Annals of Family Medicine 9
Lin 2015 PLoS ONE 6
Lomond 2014 Manual Therapy 5
Lu 2015 International Journal of Clinical and Experimental Medicine 5
(continued on next page)

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Abstracts of low back pain trials 10.e15

(continued )
First Author Year Journal Total PEDro Score 0/10
Lurie 2014 Spine 5
Macedo 2010 Fisioterapia em movimento 5
Macedo 2012 Physical Therapy 8
Machado 2010 BMC Medicine 8
Mannion 2013 The Spine Journal 5
Masse-Alarie 2013 The Clinical Journal of Pain 6
Mattila 2011 European Spine Journal 7
McGregor 2012 Spine 1
McMorland 2010 Journal of Manipulative and Physiological Therapeutics 6
Meng 2011 The Clinical Journal of Pain 6
Miyamoto 2013 Physical Therapy 8
Monro 2015 Journal of Back and Musculoskeletal Rehabilitation 6
Monticone 2015 European Journal of Pain 8
Moon 2013 Annals of Rehabilitation Medicine 8
Moon 2015 Journal of Physical Therapy Science 4
Moore 2012 The American Journal of the Medical Sciences 3
Morone 2011 European Journal of Physical and Rehabilitation Medicine 6
Morris 2011 Spine 3
Naik 2010 Indian Journal of Physiotherapy and Occupational Therapy 4
Naqaish 2013 Rawal Medical Journal 4
Nassif 2011 Archives of Physical Medicine and Rehabilitation 8
Natour 2015 Clinical Rehabilitation 8
Nazzal 2013 Neurosciences 7
Nemcic 2013 Acta Clinica Croatica 5
Oestergaard 2012 Spine 6
Ohtsuki 2012 Journal of Physical Therapy Science 2
Okafor 2012 South African Journal of Physiotherapy 2
Oke 2013 The West Indian Medical Journal 4
Olmedo-Buenrostro 2010 Revista de Investigacion Clinica 5
Omar 2012 International Journal of Rheumatic Diseases 5
Onac 2012 Journal of Cognitive and Behavioral Psychotherapies 6
Ozdemir 2015 Journal of Advanced Nursing 7
Ozkara 2015 Turkish Neurosurgery 6
Pach 2013 Evidence-Based Complementary and Alternative Medicine 5
Park 2014 Journal of Physical Therapy Science 4
Parreira 2014 Journal of Physiotherapy 9
Petersen 2011 Spine 7
Prommanon 2015 Journal of Physical Therapy Science 7
Pushpika 2010 An International Quarterly Journal of Research in Ayurveda 3
Ratajczak 2011 Journal of Back and Musculoskeletal Rehabilitation 4
Rhee 2012 Medical Science Monitor 5
Riva 2014 Journal of Medical Internet Research 6
Rogerson 2010 Pain Practice 4
Sakulsriprasert 2010 Indian Journal of Physiotherapy and Occupational Therapy 4
Saliba 2010 International Journal of Sports Physical Therapy 7
Saper 2013 Evidence-Based Complementary and Alternative Medicine 7
Selhorst 2015 The Journal of Manual & Manipulative Therapy 7
Senna 2011 Spine 8
Sharma 2011 Indian Journal of Physiotherapy and Occupational Therapy 5
Sheeran 2013 Spine 6
Sherman 2011 Archives of Internal Medicine 7
Shin 2013 Pain 8
Siemonsma 2013 Physical Therapy 7
Simmerman 2011 PM&R 4
Sokunbi 2014 South African Journal of Physiotherapy 5
Son 2014 Journal of Physical Therapy Science 3
Sorensen 2010 BMC Musculoskeletal Disorders 6
(continued on next page)

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10.e16 D.P. Nascimento et al

(continued )
First Author Year Journal Total PEDro Score 0/10
Suni 2013 Spine 5
Szlezak 2011 Manual Therapy 4
Szulc 2015 Medical Science Monitor 4
Tavafian 2011 The Clinical Journal of Pain 6
Tellez-Garcia 2015 Journal of Bodywork and Movement Therapies 7
Tilbrook 2011 Annals of Internal Medicine 5
Tilbrook 2014 Physiotherapy 4
Unsgaard-Tondel 2010 Physical Therapy 7
Vallone 2014 Photomedicine and Laser Surgery 5
Vasseljen 2010 Manual Therapy 6
Verma 2013 International Journal of Physiotherapy and Research 5
Vibe 2013 European Journal of Pain 6
Vidal 2013 European Spine Journal 5
Vieira-Pellenz 2014 Archives of Physical Medicine and Rehabilitation 8
Vincent 2014 PM&R 6
Vong 2011 Archives of Physical Medicine and Rehabilitation 6
Wajswelner 2012 Medicine and Science in Sports and Exercise 7
Wand 2013 British Journal of Sports Medicine 5
Wand 2012 The Clinical Journal of Pain 6
Weis 2013 Journal of Alternative & Complementary Medicine 9
Xia 2011 Journal of Acupuncture and Tuina Science 3
Yardley 2010 Family Practice 3
Yeh 2010 Acta Anaesthesiologica Taiwanica 2
Yeh 2011 International Journal of Nursing Studies 8
Yildirim 2010 Journal of Back and Musculoskeletal Rehabilitation 4
Yoo 2014 International Journal of Clinical Practice 4
Yoon 2012 Annals of Rehabilitation Medicine 5
You 2014 Clinical Rehabilitation 6
You 2015 Journal of Physical Therapy Science 4
Yuan 2013 Evidence-Based Complementary and Alternative Medicine 7
Yun 2012 Journal of Alternative & Complementary Medicine 6
Zahari 2014 International Journal of Pharma and Bio Sciences 3
Zaringhalam 2010 Chinese Medicine 6
Zhang 2014 The Journal of International Medical Research 6
Zheng 2012 Journal of Traditional Chinese Medicine 6

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Abstracts of low back pain trials 10.e17

Supplemental Appendix S5
Agreement of data extraction between the two authors who
collected the data. Kappa coefficient is presented for each item of
the CONSORT-A and the SPIN-checklist for both abstract and full
text (nZ200).

Item Description Kappa Coefficient


CONSORT-A applied to the abstracts 1. Title 0.96
2. Trial design 0.94
3. Participants 0.76
4. Interventions 0.47
5. Objective 0.52
6. Outcome 0.84
7. Randomization 0.75
8. Blinding 0.66
9. Numbers randomized 0.87
10. Numbers analyzed 0.72
11. Outcome results 0.35
12. Harms 0.81
13. Conclusions 0.53
14. Trial registration 0.94
15. Funding 0.87
CONSORT-A applied to the full-text 1. Title 0.96
2. Trial design 0.91
3. Participants 0.69
4. Interventions 0.57
5. Objective 0.65
6. Outcome 0.90
7. Randomization 0.70
8. Blinding 0.54
9. Numbers randomized 0.58
10. Numbers analyzed 0.84
11. Outcome results 0.60
12. Harms 0.77
13. Conclusions 0.40
14. Trial registration 0.92
15. Funding 0.87
Range from fair to almost perfect agreement Mean 0.73 (SD 0.18)
SPIN-checklist applied to the abstracts 1. Omission of primary outcome 0.82
2. Fail to mention adverse events 0.80
3. Selective reporting of outcomes 0.53
4. Fail to report statistically non-significant outcomes 0.57
5. Focus on statistically significant outcomes 0.68
6. Over-enthusiastic interpretation of outcomes 0.66
7. Recommendation of a treatment 0.49
SPIN-checklist applied to the full-text 1. Omission of primary outcome 0.81
2. Fail to mention adverse events 0.79
3. Selective reporting of outcomes 0.65
4. Fail to report statistically non-significant outcomes 0.71
5. Focus on statistically significant outcomes 0.63
6. Over-enthusiastic interpretation of outcomes 0.71
7. Recommendation of a treatment 0.53
Range from moderate to almost perfect agreement Mean 0.67 SD (0.11)

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10.e18 D.P. Nascimento et al

Supplemental Appendix S6
Agreement between abstract and full text for the classifications of
each item of the CONSORT-A and the SPIN-checklist (nZ200).
Calculated with Kappa coefficient.

Item Description Kappa Coefficient


CONSORT-A classified as “fully reported” and “not 1. Title *Not applicable
reported”. The checklist was applied to the 2. Trial design 0.33
abstract and to the full text. 3. Participants 0.12
4. Interventions 0.16
5. Objective 0.10
6. Outcome 0.45
7. Randomization 0.03
8. Blinding 0.19
9. Numbers randomized 0.10
10. Numbers analyzed 0.03
11. Outcome results 0.18
12. Harms 0.21
13. Conclusions 0.51
14. Trial registration 0.18
15. Funding 0.25
Range from slight to moderate agreement Mean 0.20 (SD 0.14)
SPIN-checklist classified as “yes” and “no”. The 1. Omission of primary outcome 0.50
checklist was applied to the abstract and to 2. Fail to mention adverse events 0.26
the full text. 3. Selective reporting of outcomes 0.49
4. Fail to report statistically non-significant outcomes 0.48
5. Focus on statistically significant outcomes 0.57
6. Over-enthusiastic interpretation of outcomes 0.53
7. Recommendation of a treatment 0.57
Range from fair to moderate agreement Mean 0.49 (SD 0.11)
* Note: The first item is ‘Not applicable’ because it is related to the title. Standard Deviation (SD).

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